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BRIEF-Soligenix Inc - Recently Had Discussions With FDA Regarding Hybryte (Sgx301) New Drug Application ( NDA ) Submission

05/07/2021 17:12
BRIEF-Soligenix Inc - Recently Had Discussions With FDA Regarding Hybryte (Sgx301) New Drug Application ( NDA ) Submission

- Soligenix Inc SNGX.O:

  • SOLIGENIX INC - RECENTLY HAD DISCUSSIONS WITH FDA REGARDING HYBRYTE (SGX301) NEW DRUG APPLICATION ( NDA ) SUBMISSION

  • SOLIGENIX - BASED UPON DISCUSSIONS, DECIDED NOT TO PURSUE ROLLING NDA SUBMISSION AT THIS TIME, IN ORDER TO PROVIDE ADDITIONAL SUPPORTIVE DATA

  • SOLIGENIX INC - NOW PLANS TO SUBMIT NDA IN FIRST HALF OF 2022 WITH CORRESPONDING POTENTIAL FDA APPROVAL ADJUSTED TO FIRST HALF OF 2023

Source text: https://bit.ly/3uHdXWZ

Further company coverage: SNGX.O


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